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FDA May Adopt ISO 13485 If Certain Changes Are Made

This article was originally published in The Silver Sheet

Executive Summary

ISO 13485, THE INTERNATIONAL QUALITY SYSTEM STANDARD, may ultimately be incorporated into FDA's Quality System Regulation - or the regulation could be replaced altogether - but the agency would want specific changes made to the ISO standard first. While the two documents are similar in many respects, "two very important issues" would have to aligned, says FDA GMP expert Kim Trautman: process validation and software validation. Industry experts comment on key differences between ISO 13485 and the QSR, and urge companies to refer to a little-known guidance document, ISO 14969, which offers advice on applying the ISO quality system standard

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